Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340555
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Brief Title:
Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss
Sponsor:
Fundació Sant Joan de Déu
Organization:
Fundació Sant Joan de Déu
Study Overview
Official Title:
Multiprofessional Healthcare Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss Enzo Study A Hybrid Controlled Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Enzo
Brief Summary:
The goal of this clinical trial is to test impact of a multiprofessional intervention in mothers and partners who suffer a pregnancy loss The main questions it aims to answer are
impact on mothers and partners mental heatlht status
reasons why mothers do not consent to the intervention
Participants will
mothers and partners will complete 4 scales
mothers and partners will participate in a interview
Researchers will compare with mothers with standard care to see if the multiprofessional intervention has an impact
impact on mothers and partners mental heatlht status
reasons why mothers do not consent to the intervention
Participants will
mothers and partners will complete 4 scales
mothers and partners will participate in a interview
Researchers will compare with mothers with standard care to see if the multiprofessional intervention has an impact
Detailed Description:
Objective 1 Evaluate the effectiveness of the multi professional intervention to reduce the intensity of grief depression anxiety and PTSD symptoms in women and their partners after pregnancy loss
Objective 2 Assess the extent to which the multiprofessional intervention was implemented as intended fidelity and understand how the intervention becomes integrated into routine healthcare practice implementation
Objective 2 Assess the extent to which the multiprofessional intervention was implemented as intended fidelity and understand how the intervention becomes integrated into routine healthcare practice implementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None